BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD DCM CR TIBIAL BEARING 10MM X 71/75MM

    MDR report key: 1884343 · Received October 27, 2010

    Report

    Report Number
    1825034-2010-00461
    Event Type
    Injury
    Date Received
    October 27, 2010
    Date of Event
    September 6, 2010
    Report Date
    September 28, 2010
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    K023546
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. REVIEW OF STERILIZATION CERTIFICATION INDICATES THE DEVICE WAS STERILIZED IN ACCORDANCE WITH BIOMET PROCEDURES. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION.THE ATTACHED USER FACILITY REPORT STATES THAT DEVICE IS AVAILABLE FOR EVALUATION. USER FACILITY WAS CONTACTED IN AN EFFORT TO OBTAIN THE DEVICE. IT WAS RELAYED BY THE USER FACILITY THAT THE DEVICE WOULD NOT BE RELEASED TO BIOMET FOR EVALUATION. ADDITIONALLY, PRODUCT IDENTIFICATION SUPPLIED BY USER FACILITY WAS INCORRECT. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT TOTAL KNEE REPLACEMENT ON (B)(6) 2010. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2010 DUE TO INFECTION. IRRIGATION AND DEBRIDEMENT WAS PERFORMED AND THE POLY BEARING WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VANGUARD DCM CR TIBIAL BEARING 10MM X 71/75MM PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 822800

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R